Medical Device Regulatory Workshops Sydney | 10-14 November 2025
The MTAA Medical Device Regulatory Workshops 2025 are a series of TGA-led sessions designed to provide comprehensive insights into the evolving regulatory landscape for medical devices in Australia. These workshops aim to equip MedTech Professionals and MedTech Startups with the latest updates, compliance strategies, and best practices to navigate regulatory requirements effectively. Attendees will gain valuable knowledge on pre-market, post-market, software as a medical device, clinical evidence and medical device regulatory basics for startups.
Monday, 1 December 2025, 9:00am - 5:00pm
Learning outcomes
- Basics of Australian Medical Device Regulations and TGA structure and personnel
- Leveraging comparable overseas regulator approvals for TGA applications
- TGA applications, variation applications, and application audits – best practice guidelines for a good submission
- TGA CA applications - best practice guidelines for a good submission
- Case studies
- Q&A with TGA
Tuesday, 2 December 2025, 9:00am - 5:00pm
Learning outcomes
- Adverse events - definitions, sponsor and manufacturer responsibilities, TGA report review process
- Recalls - flow, types, decision-making about outcomes
- Reviews, safety, reclassification, managing feedback on reforms
- Q&A with TGA
Wednesday, 3 December 2025, 9:00am - 5:00pm
Learning outcomes
- Overview of SaMD regulation
- Classification rules
- Software carve-out
- Clinical Decision Support System (CDSS)
- Evidence, artifacts, AI, cybersecurity
- Q&A with TGA
Thursday, 4 December 2025, 9:00am - 5:00pm
Learning outcomes
- Pre-clinical requirements
- Post-clinical requirements
- Q&A with TGA
Friday, 5 December 2025, 9:00am - 5:00pm
More details will be available soon.
Who Should Attend?
- MedTech Regulatory Professionals
- Academia / Students focused on the medical device industry
- Small business owners with regulatory responsibilities
- Startups/entrepreneurs
Note: These are face-to-face workshops, there are no recordings available. Placements are strictly limited.
Registration
The series contains a choice of 5 workshops, priced for members and non-members. There are discounts available for those attending the entire week.
4-Day Workshop Registration (10 - 13 November 2025)
- Members $3,564 incl. GST per person (includes all workshops excl. Startup Workshop)
- Non-Members $4,633 incl. GST per person (includes all workshops excl. Startup Workshop)
Day Registrations
- Members $990 incl. GST per person per workshop
- Non-Members $1,287 incl. GST per person per workshop
Startup Workshop Only (Friday, 14 November 2025)
- Members $750 incl. GST per person
- Non-Members $975 incl. GST per person
